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510(k) Data Aggregation
K Number
K213357Device Name
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
Manufacturer
Verily Life Sciences LLC
Date Cleared
2022-07-19
(280 days)
Product Code
DXH, DPS
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
Verily Life Sciences LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Study Watch with Irregular Pulse Monitor is indicated for use by adult patients (22 years and older) who have been diagnosed with, or are susceptible to developing, atrial fibrillation enabling them to monitor and record their heart rhythms. Study Watch is also intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms.
The Study Watch is intended for prescription use only.
Device Description
The Study Watch with Irregular Pulse Monitor is a miniaturized physiological data monitoring device that is intended to record, store, transfer and display single-channel electrocardiogram (ECG) rhythms. The Study Watch with Irregular Pulse Monitor is intended to notify the user in the event of an irregular pulse, such as atrial fibrillation (AF), and recommend acquisition of an ECG. The device utilizes a band and proprietary watch that incorporates two dedicated sensing electrodes to obtain a single-channel ECG measurement. In practice, a healthcare professional (HCP) may prescribe the Study Watch with Irregular Pulse Monitor to a patient and recommend the capture and transmission of one or more ECG rhythms on a daily basis for analysis by the HCP. The patient uses prompts provided on the graphical user interface (GUI) of the watch to collect a real-time 45-second ECG measurement. The patient is able to capture an ECG rhythm on-demand by navigation to the ECG menu, upon receipt of an irregular pulse notification. While an animated ECG waveform is briefly displayed on the GUI of the watch, the patient will not have direct access to the collected waveform. Using the provided charging dock (Cradle) and Verily's Study Hub or Watch App, the ECG measurements are securely transferred to Verily's cloud server and are viewed by the HCP using a web portal. Additionally, data may be securely transferred to interoperable devices for further analysis. The web portal is solely intended for use by the HCP to view time-stamped ECG waveforms collected by the patient and does not include any analysis features. Collectively, the Study Watch consists of the wearable watch and band, the Study Hub or Watch app (used to transfer data from the watch to the cloud), a Cradle, and the web portal.
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K Number
K192415Device Name
Study Watch with Irregular Pulse Monitor
Manufacturer
Verily Life Sciences LLC
Date Cleared
2020-01-17
(135 days)
Product Code
DXH, DPS
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
Verily Life Sciences LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Study Watch with Irregular Pulse Monitor is indicated for use by adult patients (22 years and older) who have been diagnosed with, or are susceptible to developing, atrial fibrillation enabling them to monitor and record their heart rhythms. Study Watch is also intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The Irregular Pulse Monitor is indicated for use in professional healthcare facility environments, while worn as a wrist watch.
Device Description
The Study Watch with Irregular Pulse Monitor is a miniaturized physiological data monitoring device that is intended to record, store, transfer and display single-channel electrocardiogram (ECG) rhythms. The Study Watch with Irregular Pulse Monitor is intended to notify the user in the event of irregular pulse, such as atrial fibrillation (AF), and recommend acquisition of an ECG. The device utilizes a band and proprietary watch that incorporates two dedicated sensing electrodes to obtain a single-channel ECG measurement. In practice, a healthcare professional (HCP) may prescribe the Study Watch with Irregular Pulse Monitor to a patient and recommend the capture and transmission of one or more ECG rhythms on a daily basis for analysis by the HCP. The patient uses prompts provided on the graphical user interface (GUI) of the watch to collect a realtime 60-second ECG measurement. The patient is able to capture an ECG rhythm on-demand by navigation to the ECG menu, in response to a daily ECG reminder, or upon receipt of an irregular pulse notification. While an animated ECG waveform is briefly displayed on the GUI of the watch, the patient will not have direct access to the collected wave form. Using the provided charging dock (Cradle) and Verily's Study Hub device, the ECG measurements are securely transferred to Verily's cloud server and are viewed by the HCP using a web portal. The web portal is solely intended for use by the HCP to view time-stamped ECG waveforms collected by the patient and does not include any analysis features. Collectively, the Study Watch consists of the wearable watch and band, the Study Hub (used to transfer data from the watch to the cloud), a Cradle, and the web portal.
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K Number
K182456Device Name
Study Watch
Manufacturer
Verily Life Sciences LLC
Date Cleared
2019-01-17
(132 days)
Product Code
DXH, DPS
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
Verily Life Sciences LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Study Watch is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The Study Watch is intended for use by healthcare professionals, adult patients (22 years or older) with known or suspected heart conditions, and health conscious individuals.
Device Description
The Study Watch is a miniaturized physiological data monitoring device that is intended to record, store, transfer and display single-channel electrocardiogram (ECG) rhythms. The device utilizes a band and proprietary watch that incorporates two dedicated sensing electrodes to obtain a single-channel ECG measurement. In practice, a healthcare professional (HCP) may prescribe the Study Watch to a patient and recommend the capture and transmission of one or more ECG rhythms on a daily basis for analysis by the HCP. The patient uses prompts provided on the graphical user interface (GUI) of the watch to collect a real-time 60-second ECG measurement. While an animated ECG waveform is briefly displayed on the GUI of the watch, the patient will not have direct access to the collected waveform. Using the provided charging dock (Cradle) and Verily's Study Hub device, the ECG measurements are securely transferred to Verily's cloud server and are viewed by the HCP using a web portal. The web portal is solely intended for use by the HCP to view time-stamped ECG waveforms collected by the patient and does not include any analysis features. Collectively, the Study Watch consists of the wearable watch and band, the Study Hub (used to transfer data from the watch to the cloud), a Cradle, and the web portal.
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